The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.

A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)

Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

Secondary Outcome Measures:

Total GONAL-f® Dose [ Time Frame: Start of treatment until end of stimulation cycle (approximately 28 days) ] [ Designated as safety issue: No ]

Total Number of GONAL-f® Stimulation Treatment Days [ Time Frame: Start of treatment until end of stimulation cycle (approximately 28 days) ] [ Designated as safety issue: No ]

Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment [ Time Frame: Start of treatment until Day 15-20 post-hCG ] [ Designated as safety issue: No ]

Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.

Percentage of Participants With Biochemical Pregnancies [ Time Frame: Start of treatment until Day 15-20 Post-hCG ] [ Designated as safety issue: No ]

Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.

Number of Participants With Fetal Sacs and Fetal Hearts [ Time Frame: Day 35-42 Post-hCG ] [ Designated as safety issue: No ]

Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.

GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator

Drug: GONAL f® prefilled pen

GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only

Other Names:

Follitropin alfa

Recombinant human follicle stimulating hormone (r-hFSH)

GONAL-f® Prefilled Pen

Active Comparator: Standard Dosing

GONAL-f® at a standard dose of 150 IU per day

Drug: GONAL f® prefilled pen

GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.

Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used

Between her 18th and 35th birthday (35 not included) at the time of the randomization visit

Body mass index (BMI) lower than 30 kilogram per square meter (kg/m^2) where the BMI is calculated according to the formula

Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length

Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)

Presence of both ovaries

Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy

Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization

Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy

Willing and able to comply with the protocol for the duration of the trial

Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care

Exclusion Criteria:

Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART cycles with a hyper response (defined as greater than or equal to 25 oocytes retrieved)

Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible

Have previous severe ovarian hyperstimulation syndrome (OHSS)

Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS

Presence of endometriosis requiring treatment

Uterine myoma requiring treatment

Any contraindication to being pregnant and/or carrying a pregnancy to term

Extra-uterine pregnancy within the last 3 months prior to screening

History of 3 or more miscarriages (early or late miscarriages) due to any cause

Tumors of the hypothalamus and pituitary gland

Ovarian enlargement or cyst of unknown etiology

Ovarian, uterine or mammary cancer

A clinically significant systemic disease

Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,

Abnormal gynecological bleeding of undetermined origin

Known allergy or hypersensitivity to human gonadotrophin preparations,

Any active substance abuse or history of drug medication or alcohol abuse in the past 5 years prior to the screening visit

Entered previously into this trial or simultaneous participation in another clinical trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829244